Test Price
1,000 AED✅ Home Collection Available
Tacrolimus Genotyping (CYP3A5) Test in UAE | 1000 AED | DHA Licensed Laboratory
Executive Summary & Core Metrics
- 99.9% Diagnostic Sensitivity via ISO 15189:2022 accredited real-time PCR molecular processing with orthogonal sequencing confirmation.
- Premium Logistics: VIP Mobile Phlebotomy & Temperature-Controlled Cold-Chain Home Collection available daily from 8 AM to 11 PM.
- Clinical Guidance: Complimentary Telephonic Post-Test Counselling from a Consultant Medical Geneticist for result interpretation and dosing strategy support.
- Insurance: Direct Billing Verification via WhatsApp at +971 54 548 8731.
Test Overview & Methodology
Tacrolimus Genotyping (CYP3A5) identifies single-nucleotide polymorphisms in the CYP3A5 gene that govern tacrolimus metabolism rate. This pharmacogenomic assay enables pre-therapy dose individualisation for kidney, liver, and heart transplant recipients, reducing the incidence of acute rejection and drug-induced nephrotoxicity. The analysis is performed on peripheral whole blood using real-time PCR with melt-curve analysis, followed by Sanger sequencing for variant confirmation when required.
| Feature | Our Test (CYP3A5 Genotyping) | Closest Alternative (Serum Trough Monitoring) |
|---|---|---|
| Methodology | Real-Time PCR (qPCR) with Sanger confirmation | Immunoassay (CMIA / FPIA) |
| Predictive Precision | Genotype-based, pre-therapy, personalised dosing | Reactive; requires steady-state drug levels |
| Turnaround | Monday/Thursday sample → Wednesday/Saturday report (4–5 days) | Same day or next day |
| Clinical Value | Prevents toxicity and rejection before first dose | Adjusts dose after a potential adverse event |
Physician Insight & Safety Protocols
“CYP3A5 genotyping delivers a pre-emptive roadmap for tacrolimus dosing that can significantly shorten the time to therapeutic target and reduce early graft complications. However, the genotype result must be weighed alongside renal function, concomitant cytochrome inhibitors or inducers, and the patient’s immunological risk profile. This test enriches clinical decision-making—it does not replace the transplant physician’s comprehensive assessment.”
— Lina Osama Zaki Quteineh, Consultant Medical Genetics | DHA Registration ID: 9294403
Clinical Advisory
This pharmacogenomic test is a dosing guidance tool only. Do not initiate, discontinue, or alter tacrolimus therapy solely upon genotyping results. All dose adjustments must be prescribed and supervised by a qualified transplant physician who integrates the genetic data with serial therapeutic drug monitoring, renal function trends, and clinical status.
Exclusion Criteria
- Contraindicated: Whole blood transfusion within 30 days or prior haematopoietic stem cell transplantation may yield misleading genotype results due to donor-derived DNA.
- Documentation required: Concurrent use of strong CYP3A4/5 inducers (e.g., rifampicin) or inhibitors (e.g., ketoconazole) must be recorded for accurate dose modelling but does not preclude testing.
- Emergency warning: Signs of acute organ rejection—fever, graft site tenderness, oliguria, dyspnoea—require immediate hospital evaluation. This genetic test does not diagnose acute rejection.
Patient FAQ & Clinical Guidance
1. Who should undergo Tacrolimus Genotyping (CYP3A5) testing?
CYP3A5 genotyping is primarily indicated for kidney transplant recipients prior to initiating tacrolimus to achieve target trough levels faster. It is also appropriate for liver or heart transplant candidates and any patient requiring long-term tacrolimus therapy where the risk of toxicity or subtherapeutic exposure is elevated.
2. How does CYP3A5 genotype affect tacrolimus dosage?
Individuals carrying at least one CYP3A5*1 allele (expressors) metabolise tacrolimus rapidly and typically require 1.5–2.5 times higher daily doses to reach therapeutic blood concentrations. Non-expressors (homozygous CYP3A5*3) are slow metabolisers and need substantially lower doses to avoid supratherapeutic levels and associated nephrotoxicity.
3. What sample is required and what is the turnaround time?
A 3 mL peripheral whole blood specimen collected in an EDTA (lavender-top) tube is required. No fasting or special preparation is needed. VIP Mobile Phlebotomy collects samples at your home between 8 AM and 11 PM daily. Samples collected Monday before 11 AM produce a report by Wednesday; Thursday collections yield results by Saturday.
UAE Regulatory & Data Privacy Adherence
Regulatory Compliance Framework
DNA Labs UAE operates under DHA Facility License Number 1143 and adheres to the UAE Federal Decree-Law No. 45 of 2021 on Personal Data Protection (PDPL) for all patient genetic data processing, storage, and sharing. Clinical laboratory operations comply with Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields. All test procedures and patient consent protocols follow Federal Decree-Law No. 4 of 2016 on Medical Liability, ensuring safe, transparent pharmacogenomic testing.
Clinical & Logistical Metadata
| Test Name | Tacrolimus Genotyping (CYP3A5) |
| Price (AED) | 1,000 |
| Turnaround Time | 4–5 working days (Monday/Thursday submission → Wednesday/Saturday report) |
| Sample Type / Matrix | Peripheral whole blood (3 mL EDTA tube); VIP Mobile Phlebotomy & Temperature-Controlled Cold-Chain Home Collection available daily 8 AM–11 PM |
| Methodology Used | Real-Time PCR (qPCR) with melt-curve analysis and Sanger sequencing confirmation |
| ICD-10-CM Code | Z13.89 |
| LOINC Code | 69071-2 |
| DHA Facility License & Address | License: 1143 | Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE | DNA Labs UAE |
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